MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-09-28 for CORTISOL 11875116122 manufactured by Roche Diagnostics.
[26882504]
Patient Sequence No: 1, Text Type: N, H10
[26882565]
The customer reported that they received questionable results for a total of 28 patient saliva samples tested for cortisol. The samples were being tested as part of a lot to lot correlation on the e601 analyzer. Of the 28 samples, fourteen were found to have erroneous results that were reported outside of the laboratory. The results obtained with the current reagent lot number 178322 were high compared to results from the new reagent lot number 185380. The customer stated that they had noticed with increased frequency that controls were outside of range and patient results had been increasing. The results obtained with the current lot 178322 were reported outside of the laboratory. The results obtained with new lot 185380 were believed to be correct. The pathologist did not deem the difference in results to be clinically significant, so the results that had been reported outside of the laboratory were not corrected. The first patient sample resulted as 0. 396 ug/dl when tested with the current lot and resulted as 0. 241 ug/dl when tested with the new lot. The second patient sample resulted as 0. 353 ug/dl when tested with the current lot and resulted as 0. 203 ug/dl when tested with the new lot. The third patient sample resulted as 0. 286 ug/dl when tested with the current lot and resulted as 0. 176 ug/dl when tested with the new lot. The fourth patient sample resulted as 0. 864 ug/dl when tested with the current lot and resulted as 0. 546 ug/dl when tested with the new lot on (b)(6) 2015. This patient was a (b)(6). The fifth patient sample resulted as 0. 140 ug/dl when tested with the current lot and resulted as 0. 018 ug/dl when tested with the new lot on (b)(6) 2015. The sixth patient sample resulted as 0. 222 ug/dl when tested with the current lot and resulted as 0. 071 ug/dl when tested with the new lot on (b)(6) 2015. The seventh patient sample resulted as 0. 483 ug/dl when tested with the current lot and resulted as 0. 232 ug/dl when tested with the new lot on (b)(6) 2015. The eighth patient sample resulted as 63. 44 ug/dl when tested with the current lot and resulted as 39. 30 ug/dl when tested with the new lot on (b)(6) 2015. The ninth patient sample resulted as 0. 191 ug/dl when tested with the current lot and resulted as 0. 037 ug/dl when tested with the new lot on (b)(6) 2015. The tenth patient sample resulted as 0. 452 ug/dl when tested with the current lot and resulted as 0. 256 ug/dl when tested with the new lot on (b)(6) 2015. The eleventh patient sample resulted as 0. 297 ug/dl when tested with the current lot and resulted as 0. 183 ug/dl when tested with the new lot on (b)(6) 2015. The twelfth patient sample resulted as 0. 300 ug/dl when tested with the current lot and resulted as 0. 157 ug/dl when tested with the new lot on (b)(6) 2015. The thirteenth patient sample resulted as 0. 774 ug/dl when tested with the current lot and resulted as 0. 485 ug/dl when tested with the new lot on (b)(6) 2015. The fourteenth patient sample resulted as 0. 164 ug/dl when tested with the current lot and resulted as 0. 020 ug/dl when tested with the new lot on (b)(6) 2015. The patients were not adversely affected. The e601 analyzer serial number was (b)(4). The field service representative determined that the issue was caused by the older, current reagent lot number. The customer switched to the new lot number. Calibration and controls passed according to the customer's ranges. The field application specialist determined that the older, current lot was not recovering as expected. The new lot number was recovering within acceptable limits.
Patient Sequence No: 1, Text Type: D, B5
[31054199]
A specific root cause could not be determined based on the provided information. Calibration effects are considered to contribute to the customer observed initial lot deviation. Both reagent lots showed higher than expected recovery for one of the calibrators. The quality control recovery trend was found to contradict the findings of the patient sample comparison. Internal method comparison data shows excellent agreement between the reagent lots in question.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04226 |
| MDR Report Key | 5107564 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-28 |
| Date of Report | 2015-10-23 |
| Date of Event | 2015-08-26 |
| Date Mfgr Received | 2015-09-08 |
| Date Added to Maude | 2015-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORTISOL |
| Generic Name | ENZYME IMMUNOASSAY, CORTISOL, SALIVARY |
| Product Code | NHG |
| Date Received | 2015-09-28 |
| Model Number | NA |
| Catalog Number | 11875116122 |
| Lot Number | 17832201 |
| ID Number | NA |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-28 |